a study to assess the effects of nemolizumab on cytochrome p450 substrates in participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the effect of nemolizumab (cd14152) on the pharmacokinetics (pk) of a drug "cocktail" representative of cyp450 (cyp1a2, cyp2c9, cyp2c19, cyp2d6 and cyp3a4/5 sensitive index substrates) in adult participants with moderate to- severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * chronic atopic dermatitis (ad) for at least 2 years before the screening visit, and confirmed according to american academy of dermatology consensus criteria at the time of the screening visit * eczema area and severity index (easi) score greater than or equal to (\>=) 16 at both the screening and baseline visits * iga score \>= 3 (based on the investigator's global assessment \[iga\] scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits * ad involvement \>=10 percent (%) of body surface area (bsa) at both the screening and baseline visits * peak (maximum) pruritus numeric rating scale (pp nrs) score of at least 4.0 at both the screening and baseline visit * documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (topical corticosteroid \[tcs\] with or without topical calcineurin inhibitor \[tci\]) exclusion criteria: * body weight less than (\<) 45 kilogram (kg) * participants meeting 1 or more of the following criteria at screening or baseline: (a) had an exacerbation of asthma requiring hospitalization in the preceding 12 months; (b) reporting asthma that has not been well-controlled in the previous 3 months; (c) asthma control test (act) \<= 19 (for those with a history of asthma); (d) peak expiratory flow \< 80% of the predicted value * participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis * cutaneous infection within 1 week prior to the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks prior to the baseline visit, or any confirmed or suspected coronavirus disease (covid)-19 infection within 2 weeks before the screening or baseline visit. participants may be rescreened once the infection has resolved. resolution of covid-19 infection can be confirmed by recovery assessment methods * requiring rescue therapy for ad during the screening period or expected to require systemic rescue therapy during the treatment period * positive serology results (hepatitis b surface antigen \[hbsag\] or hepatitis b core antibody \[hbcab\], hepatitis c antibody, or human immunodeficiency virus antibody) at the screening visit * treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to screening * known active or latent tuberculosis * treatment with biologics and their biosimilars within 8 weeks from screening * use of phototherapy or tanning beds within 4 weeks from screening * use of medication known as inducer, inhibitor, or competitive substrate of one or more of the following cytochrome (cyp) enzymes: cyp3a4/5, cyp2c19, cyp2c9, cyd2d6, and cyp1a2 within 2 weeks from screening * treatment with midazolam, omeprazole, warfarin sodium, metoprolol tartrate within 2 weeks from screening * history of hypersensitivity or intolerance to cyp substrates and their excipients * participants for whom administration of the cyp substrates provided in this study is contraindicated or medically inadvisable * participants with international normalized ratio (inr) \> 1.5 * consumption of any 1 or more of the following food items and/or beverages within 1 week prior to baseline: grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice, cranberries or cranberry juice; vegetables from the mustard green family (eg, broccoli, kale); charbroiled meats; beverages, foods, or drugs containing caffeine * history of or current confounding skin condition * current smokers